The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

Spondylolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective evidence of neurological impairment
Trauma (i.e., fracture or dislocation)
Spinal stenosis .
Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
Pelvic obliquity ●
Spinal tumor
Pseudarthrosis
Failed previous fusion

The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Device Description

Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.

AI/ML Overview

The U&I Corporation's Perfix™ Iliac Screw System underwent non-clinical (bench) testing to demonstrate its performance and establish substantial equivalence to predicate devices. The study aimed to show that the device met established acceptance criteria, indicating no new safety or efficiency issues compared to existing, legally marketed spinal fixation systems.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the mechanical performance of the Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices. However, the exact numerical acceptance criteria for each test and the specific reported performance values for the Perfix™ system are not detailed in the provided text. The document generally confirms that the tests were performed and the device met the criteria.

Acceptance Criteria (General Description from Predicate Devices)	Reported Device Performance (Perfix™ Iliac Screw System)
Static compression bending performance (ASTM F1717)	Met acceptance criteria
Static torsion performance (ASTM F1717)	Met acceptance criteria
Dynamic compression bending performance (ASTM F1717)	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of devices or constructs tested for the "test set" in the performance testing.
Data Provenance: The study was a non-clinical setting (bench testing). Data provenance is not geographical in this context, but rather refers to the type of experimental setup. It is retrospective in the sense that the acceptance criteria were established from existing predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this study. The "ground truth" for this type of mechanical performance testing is defined by established engineering standards (ASTM F1717) and the performance of predicate devices, not by expert medical opinion on individual cases.

4. Adjudication Method for the Test Set

This question is not applicable to this study. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple observers. This study involved mechanical testing against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the mechanical performance of a medical device, not on the interpretative performance of human readers, with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a physical spinal implant system, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The performance testing was for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

Established industry standards: Specifically, ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
Performance of predicate devices: The Perfix™ Iliac Screw System was compared directly against the mechanical performance of the Synergy™ Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096), and Global Spinal Fixation System™ (K001668). The acceptance criteria were derived from these predicate devices.

8. The Sample Size for the Training Set

This question is not applicable to this study. There is no concept of a "training set" in a mechanical bench testing study for a physical device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there was no training set.

Summary

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K132218 - Page 1 of 3

DEC 1 7 2013

Manufacturer: U & I Corporation 20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do, Korea, 480-859 Sponsor: U & I Corporation 20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do, Korea, 480-859 Sponsor Contact: Young-Geun, Kim, Regulatory Affairs Assistant +82 31 852 0102 (ext.619) ygkim@youic.com Dec 17, 2013 Date Prepared: Trade Name: Perfix™ Iliac Screw System Device Name: Spinal Fixation System, per 21 CFR 888.3050 and 888.3070 Classification Name: Spinal Fixation System Common Name: Product Code: MNH, MNI, KWP Synergy™ Spinal System – Synergy VLS Screws (K011437) Predicate Devices: OPTIMA™ Spinal System (K024096) Global Spinal Fixation System™ (K001668)

Perfix™ Iliac Screw System

510(k) Summary

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Description of Device:

Intended Use:

Spondylolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective evidence of neurological impairment
Trauma (i.e., fracture or dislocation)
Spinal stenosis .
Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
Pelvic obliquity ●
Spinal tumor
Pseudarthrosis
Failed previous fusion

Substantial Equivalence:

The Perfix™ Iliac Screw System is substantially equivalent to Synergy "" Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096) and Global Spinal Fixation System™ (K001668) in design, material, mechanical performance, function and intended use.

The mechanical performance of Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices.

Perfix™ Iliac Screw System

CORPORATION

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1. Comparison Technological Characteristics

The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;

The similar indications for use .
Similar design features
Incorporate the same or similar materials
The equivalent mechanical performance

2. Performance Testing

The Perfix™ Iliac Screw System was tested in a non clinical setting (bench testing) to assess that to know new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Perfix™ Iliac Screw System is substantially equivalent to the predicate devices.

The following tests were performed:

1. Construct Test (ASTM F1717)
- (1) Static compression bending test
- (2) Static torsion test
- (3) Dynamic compression bending test

3. Conclusion

The data and information provided in this submission support the conclusion that the Perfix™ Iliac Screw System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

U&i CORPORATION

Perfix™ Iliac Screw System

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the left.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2013

U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Assistant 20. Sandan-ro. 76beon-gil (Rd) Uijeongbu-si, Gyeonggi-do Republic of Korea 480-859

Re: K132218

Trade/Device Name: Perfix™ Iliac Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNH, KWP Dated: November 14, 2013 Received: November 15, 2013

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Young-Geun Kim

forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MédicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

RonaldFP: Jean -S for

Mark N: Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

K132218 510(k) Number (if known):

Device Name: Perfix™ Iliac Screw System

Indications for Use:

Spondvlolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective evidence of neurological . impairment
Trauma (i.e., fracture or dislocation) ●
Spinal stenosis œ
Spinal deformities (Scoliosis, Kyphosis, Lordosis)
Pelvic obliquity
Spinal tumor
Pseudarthrosis
Failed previous fusion

The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, illiac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zane W. Wyatt -S

(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K132218 Perfix™ illiac Screw System

U&i CORPORATION

Regulation Number and Section

N/A